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Monitoring Cellular Immunity After Kidney and Liver Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683748
First Posted: May 23, 2008
Last Update Posted: February 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Uppsala University Hospital
Information provided by:
Karolinska University Hospital
  Purpose
After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.

Condition
Terminal Kidney Failure Terminal Liver Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Cellular Immunity After Kidney and Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • T cell reactivity to viral antigens [ Time Frame: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation ]

Biospecimen Retention:   Samples Without DNA
Serum, whole blood

Estimated Enrollment: 100
Study Start Date: March 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Kidney transplant
Liver transplant

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing kidney or liver transplantation at the Karolinska University Hospital
Criteria

Inclusion Criteria:

  • All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

Exclusion Criteria:

  • Abscence of informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683748


Locations
Sweden
Lars Wennberg
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Uppsala University Hospital
Investigators
Principal Investigator: Lars Wennberg, MD, PhD Karolinska University Hospital
Study Director: Gunnar Tyden, MD, PhD Karolinska University Hospital
  More Information

Responsible Party: Lars Wennberg, Associate Professor, Karolinska University Hospital, Department of Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00683748     History of Changes
Other Study ID Numbers: T cell study
First Submitted: May 21, 2008
First Posted: May 23, 2008
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by Karolinska University Hospital:
Transplantation
Immunological monitoring
Immunological risk
T cell reactivity
Cellular immunity

Additional relevant MeSH terms:
Renal Insufficiency
Liver Failure
Kidney Diseases
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases